The Effect of Message Framing in Diabetic Foot Self-Management on Diabetic Foot Care Behaviors and Self-Efficacy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Ataturk University
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Assessment of Foot Care Behavior
Study Overview
Brief Summary
This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages.
Study Design:
A randomized controlled trial with three groups:
Experimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care.
Experimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care.
Control Group (Routine Messaging): Participants receive standard foot care messages without specific framing.
Participants:
Diabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications.
Intervention:
Over a period of three months, participants will receive WhatsApp messages three times a week.
Gain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear.
Loss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care.
Messages will include supportive images and videos to enhance engagement and understanding.
Outcome Measures:
Primary Outcomes:
Foot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention.
Significance:
This study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.
Detailed Description
Title: The Effect of Message Framing on Self-Efficacy and Foot Care Behaviors in Diabetic Foot Care: A Randomized Controlled Study
Abstract:
This study aims to examine the effect of message framing on self-efficacy and foot care behaviors in diabetic foot care. Evaluating the impact of message framing on self-efficacy and foot care behaviors is crucial in reducing the economic burden of diabetic foot on healthcare services while simultaneously improving patients' quality of life and daily functionality. The results of this study are expected to contribute to interventions aimed at enhancing self-efficacy in diabetic foot care and preventing diabetic foot complications.
Study Setting and Population:
Patients will be recruited through diabetes-related social media groups. Eligible participants who agree to participate will be contacted via WhatsApp, where they will receive framed messages.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals aged between 18 and 55 years.
- •Individuals diagnosed with diabetes for at least six months.
- •Individuals without diabetic foot ulcers or amputations.
- •Individuals without any communication disorders or psychiatric illnesses.
- •Individuals who are members of a social media platform.
- •Individuals who can use a smartphone and have internet access.
- •Individuals willing to participate in the study.
- •Individuals with at least a primary school education.
Exclusion Criteria
- •Individuals diagnosed with diabetes (This criterion seems unclear; please clarify if it should refer to a specific diabetes-related condition).
- •Individuals with diabetic foot ulcers or amputations.
- •Individuals with any communication disorders or psychiatric illnesses.
- •Individuals without access to a smartphone or the internet.
- •Individuals with malingering disorders.
- •Individuals who are illiterate.
Arms & Interventions
Control Group
Participants will receive neutral messages about diabetic foot care.
Group 1 (Gain-Framed)
Participants receive gain-framed messages emphasizing the benefits of proper foot care.
Intervention: Gain- Framed Messages (Behavioral)
Group 2 (Loss-Framed)
Participants receive loss-framed messages highlighting the risks of inadequate foot care.
Intervention: Lost Framed Messages (Behavioral)
Outcomes
Primary Outcomes
Assessment of Foot Care Behavior
Time Frame: 3 month
Foot Care Behavior Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Foot Care Behavior Scale from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score of the Foot Care Behavior scale is 15 and the highest score is 75. The increase in the scale score indicates that the individual's self-care behaviors are better
Diabetic Foot Care Self-Sufficiency Level
Time Frame: 3 months
Diabetic Foot Care Self-Efficacy Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Diabetic Foot Care Self-Efficacy Score from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score that can be obtained from the Diabetic Foot Care Self-Efficacy Scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehtap KAVURMACI
Prof.
Ataturk University